3Shape A/S China

Regulatory Affairs Specialist/Manager

Responsibility:

  • Provide the Regulatory Affairs department with country specific regulatory input supporting product development and product lifecycle management
  • Ensure regulatory approval and maintenance of products (active devices and software as a medical device) and in collaboration with regulatory consultants, if relevant
  • Review product and packaging labels, IFUs, marketing material
  • Answer questions from Competent Authorities concerning regulatory topics in collaboration with Regulatory Affairs department  and/or regulatory consultants, if relevant.
  • Responsible for communication with Competent Authorities with regard to vigilance cases, recalls and FSNs in collaboration Regulatory Affairs department and/or regulatory consultant, if relevant
  • Communication with customers regarding regulatory issues
  • Ensure that the company's policies, procedures and operating guidelines conform to country specific laws, regulations and industry practices.
  • Responsible for the daily collaboration with regulatory consultants as well as evaluation of performance and costs.
  • If decided, establish and maintain procedures required for local 3Shape entity to act as Marketing Authroisation holder
  • Act as qualified person for local 3Shape office, if required by Competent Authority
  • Act as QMS Management Representative, if required by Competent Authority
  • Act as local responsible person for post-market surveillance activities, if required by Competent Authority

Requiremnets:

  • Eudcation: Relevant technical, engineering or natural science  background, preferably a university degree
  • Experience with regulatory affairs from a medical device company, preferably with active devices and/or software devices
  • Familiar with country specific Medical Device regulation (PMDA, KFDA, ANVISA, CFDA) as well as ISO13485, ISO 62304, Low Voltage Directive and EMC Directive etc.
  • Excellent planning, cooperation, and communication skills
  • Fluent in English with excellent verbal and written communication skills

Share on:

Reference No.:

VW

Region:

  • 上海巿 (Shanghai)

Job type:

Regular

Working hours:

Full-time

Working days:

Day

Application deadline:

asap

Expected Start Date:

asap

Location:

Shanghai, China

Company homepage:

http://www.3shape.com

Office address:

Room 906, Tower A Eton Place 69 Dongfang Road 201-120 Shanghai